Visia AF MRI™ VR SureScan™ DVFB1D4 (UDI 00643169720794)Recalls & reported problems

Summary

The FDA's MAUDE database contains 645 adverse event reports that list this exact device (DI 00643169720794), received between Apr 25, 2018 and Sep 30, 2026 — classified as 10 deaths, 511 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (233 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 10, 2023Class IOpen, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1804-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 645 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) possibly inappropriately withheld high-voltage therapy for Ventricular Fibrillation (VF) to the patient by wavelet discriminator noted on some Supra Ventricular Tachycardia (SVT) episodes. The ICD remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50949546 ↗
• InjurySep 18, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50829435 ↗
• InjurySep 9, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699665 ↗
• MalfunctionAug 12, 2026Pacing Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226935 ↗
• InjuryJul 29, 2026Signal Artifact/Noise; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient had a procedure using cautery. Prior to the procedure, there were no issues with Implantable Cardioverter Defibrillator (ICD) pacing or the patient's heart rate. However, during the procedure the patient's heart rate was interrupted. A magnet was not placed on the patient's ICD at the beginning of the procedure. The magnet was placed over an hour into the procedure. At the time the magnet was placed, the patient's heart rate went to forty beats per minute and the device's lower rate was set to that. During the procedure, prior to the magnet being placed, a Lead Integrity Alert (LIA) triggered for High Rate Non-Sustained episodes and short ventricular intervals. An abrupt increase in Right Ventricular (RV) lead impedance was noted along with oversensing noise on the triggering misclassification of events and inappropriate high-voltage therapy. The ICD remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Non specific EKG/ECG Changes; Shock from Patient Lead(s)

  MAUDE report 50074826 ↗
• InjuryJul 28, 2026Insufficient Device Problem Information

  It was reported that the Implantable Cardioverter Defibrillator (ICD) was explanted and replaced non-prophylactically. No patient co mplications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063431 ↗
• MalfunctionJun 12, 2026Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTION ISSUE NOTED AS POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED AS VENTRICULAR TACHYCARDIA (VT).  THE ICD REMAINS IN USE.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490168 ↗
• MalfunctionJun 3, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LONGEVITY ESTIMATION DECREASED MORE THAN EXPECTED IN A SHORT PERIOD OF TIME. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382640 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. VEGETATION WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 25222360 ↗
• InjuryMay 12, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO WHAT WAS NOTED AS A GRADUAL INCREASE IN VENTRICULAR TACHYCARDIA (VT) MONITOR ZONE TO VENTRICULAR FIBRILLATION (VF).  REVIEW BY THE TECHNICAL SERVICE AGENT INDICATED THAT IT WAS DIFFICULT TO DETERMINE WHETHER ATRIAL OR VENTRICULAR IN NATURE OR AS A RESULT OF POST SHOCK.  THE ICD REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25152235 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO A FUNGAL INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fungal Infection

  MAUDE report 25140208 ↗
• InjuryApr 15, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE INAPPROPRIATELY WITHHELD THERAPY FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT) VIA WAVELET. THE ICD DETECTED VT SEVERAL MINUTES LATER AND TREATED WITH ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY. IT WAS NOTED THAT THE PATIENT REQUIRED EXTERNAL DEFIBRILLATION TWICE. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24889347 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT EXPERIENCED A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. THE DEVICE SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 24783356 ↗
• InjuryMar 30, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE ICD WAS FUNCTIONING NORMALLY, THE DEVICE WAS ONLY REPLACED AT THE TIME OF THE RV LEAD REPLACEMENT DUE TO THE AMOUNT OF BATTERY LONGEVITY REMAINING.

  Patient problems: Pain

  MAUDE report 24719733 ↗
• InjuryMar 13, 2026Pacing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POSSIBLE INAPPROPRIATE WITHHOLDING OF THERAPIES FOR  VENTRICULAR FIBRILLATION (VF) THAT WAS DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24598620 ↗
• MalfunctionMar 12, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM AND EXPERIENCING HYPOTENSION AND BRADYCARDIA. THE HEALTHCARE PROFESSIONAL STATED 'WE'RE NOT SEEING PACER SPIKES.' THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 24582550 ↗
• MalfunctionMar 9, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DETECTED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR) AS A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552947 ↗
• InjuryMar 9, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE PATIENT WAS EXPERIENCING PAIN IN RIGHT SIDE OF CHEST STARTED THAT STARTED TODAY. THE PATIENT REPRESENTATIVE ALSO NOTED THAT THE PATIENT HAS EXPERIENCED GRAND MAL SEIZURES FOR THE PAST FEW YEARS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Convulsion/Seizure; Pain

  MAUDE report 24552757 ↗
• InjuryFeb 25, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24443846 ↗
• InjuryFeb 24, 2026Failure to Deliver Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK FOR DETECTED VENTRICULAR TACHYCARDIA (VT) THAT MAY HAVE BEEN SUPRA VENTRICULAR TACHYCARDIA (SVT). ADDITIONALLY, THERAPY MAY HAVE BEEN WITHHELD FOR A DETECTED SVT THAT MAY HAVE BEEN VT. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s); Tachycardia

  MAUDE report 24436414 ↗
• MalfunctionFeb 23, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODES AS VENTRICULAR TACHYCARDIA (VT). THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423635 ↗
• InjuryFeb 11, 2026Device Sensing Problem

  IT WAS FURTHER REPORTED VIA THE FOLLOWING CLINIC THAT THERE WAS NO ICD DETECTION ISSUE AND THE REPLACEMENT PROCEDURE WAS NOT DUE TO A DETECTION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317852 ↗
• InjuryFeb 5, 2026Pacing Problem

  IT WAS REPORTED BY THE PATIENT AND THEIR REPRESENTATIVE THAT THE PATIENT WAS PUNCHED IN THE CHEST AT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SITE REALLY HARD AND PASSED OUT. UPON WAKING, THE PATIENT EXPERIENCED DIZZINESS AND "COULD BARELY WALK". APPROXIMATELY THREE WEEKS LATER, THE PATIENT EXPERIENCED CHEST PAIN AND NOTED BUMPS AROUND THE ICD THAT WERE "REALLY HARD, LIKE THE [RIGHT VENTRICULAR] LEAD IS PROTRUDING OR POKING THROUGH¿. THE PATIENT WAS EVALUATED BY EMERGENCY MEDICAL PERSONNEL WHO INFORMED THE PATIENT THAT THE ICD WAS OVER-PACING. THE ICD AND RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT..

  Patient problems: Chest Pain; Dizziness; Syncope/Fainting

  MAUDE report 24269444 ↗
• InjuryFeb 5, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD POSSIBLY WITHHELD THERAPY DURING THE PATIENT'S VENTRICULAR TACHYCARDIA (VT). THE EPISODE WAS INITIALLY DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD REMAINS IN USE. NO FURTHER PAT IENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24267823 ↗
• InjuryJan 14, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) EPISODES. THE IMPLANTABLE CARDIOVERTER D EFIBRILLATOR (ICD) WAS REPROGRAMMED SO AS NOT TO PROVIDE THERAPY FOR SLOWER RATES. AS A RESULT, THE PATIENT EXPERIENCED SYNCOPE FROM SUSTAINED VENTRICULAR TACHYCARDIA (VT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s); Syncope/Fainting; Tachycardia

  MAUDE report 24072224 ↗